Guidewire and Implantable Electrode Line

ABSTRACT

A guide wire for introducing an implantable electrode line, wherein the electrode line is a heart electrode line for intracardial sensing of cardiac action potentials and/or for electrical stimulation or defibrillation of the heart, and wherein the guide wire has means for removable interlocking of its end at or near the proximal end of the electrode line.

BACKGROUND OF THE INVENTION

The invention relates to a guide wire for introducing an implantableelectrode line, in particular a heart electrode line for intracardialsensing of cardiac action potentials and/or for electrical stimulationor defibrillation of the heart as well as a corresponding electrode lineitself, and finally a combination of a guide wire and an electrode line.

Implantable electrode lines with said functions have been known for along time and in a great variety of forms in connection with implantablepacemakers or defibrillators heavily used in practice. Since theseelectrode lines, due to the course of the vascular system in which theyextend from the implantable device into the heart of the patient, musthave a high degree of flexibility, a guide wire is needed as a tool fortheir implantation. In order to be able to receive the guide wire, theelectrode lines have a cavity extending in the longitudinal direction,the so-called lumen. With the guide wire used, the electrode line can beguided, with observation of its path by means of an imaging process,with precise targeting into heart, where, if needed, it is possible, byturning a grip on the proximal end of the guide wire, to steer itsdistal end, provided with a curvature, in the desired direction.

In the case of the known implantation processes of this type the guidewire (mandrin) is pushed in up to the distal stop in the electrode line.Thereby the electrode is, if necessary, stretched and obtains a curveand rigidity, which make possible its introduction into the heartthrough the (venous) vascular system—which however assumes that theguide wire remains in place reliably, essentially over the entireextension of the lumen of the electrode line. As a consequence of thediverse manipulations by the implanter however, unintended displacementsoccur relatively frequently in the customary arrangements and undercertain circumstances the guide wire slips out of the lumen of theelectrode line.

From U.S. Pat. No. 5,497,782 a lockable guide wire for inserting andreplacing a dilatation catheter is known. There a spirally expandablesection of the guide wire serves for its reliable positioning relativeto a lesion when the dilatation catheter pulled out and replaced by anew one.

From U.S. Pat. No. 6,027,461 an infusion guide wire with fixed core wireis known. The proximal end of this core wire is affixed to a proximalconnecting housing for the connection of an infusion lumen.

BRIEF DESCRIPTION OF THE INVENTION

The objective of the invention consists of specifying an improved guidewire for an implantable electrode line or a corresponding electrode lineper se, which insures a reliable and rapid implantation even underadverse circumstances, for example, in the case of a very unfavorablegeometric course of the vascular systems and the corresponding necessityof complicated handling on the part of the implanter.

This objective is realized according to a first aspect of the inventionby a guide wire with the features of claim 1 and according to a secondaspect by an electrode line with the features of claim 11.

The invention comprises the fundamental concept of providing a mutualinterlocking between the guide wire and electrode line for fastening themandrin in the lumen of the electrode line during the implantationprocess. It further comprises the concept of providing a fastening orinterlocking of this type on or near the proximal end of theelectrode-mandrin arrangement in order, after finishing theimplantation, to be able to detach it once again as easily as possible.It is to be noted in this, that the proposed fixation does notnecessarily assume that the guide wire has been pushed in completely upto the distal end of the electrode line lumen.

A first expedient form of embodiment provides a deformation, inparticular curved, wavy, V-shaped, zig-zag, or trapezoidal, enlargingthe effective contact diameter of the guide wire to a valuecorresponding essentially to the inner diameter of a lumen of theelectrode line or greater than this. The high degree of elasticity ofthe material of the guide wire, in conjunction with this impresseddeformation, leads to the guide wire being pressed pointwise (at onepoint or several points) elastically against the wall of the lumen,whereby a frictional lock with the electrode line, and thus the desiredlocking, is realized. Said deformation represents a particularly simplefixation means.

In an alternative embodiment the fixation means is a thickening, formedon or fixedly applied, which has an engagement section tapering towardthe distal end of the guide wire, in particular in the form of thefrustum of a cone, for force-locking engagement with a lumen of theelectrode line. Said thickening can be a thin cone, but also an elementwith one or more curved surfaces, and it can, for example, consist ofmetal or also of plastic and be welded or glued to the actual guidewire.

An additional alternative embodiment provides a first catching means,formed on or fixedly applied, which is formed to work together withcorrespondingly formed and disposed second catching means on theelectrode line. Catching means of this type are known per se and need nofurther description here.

An additional, from the present view preferred, embodiment comprises anattached or mounted split taper socket, which is formed to engage a plugpin of the electrode line and to produce a force-locking engagement withit. In this case the split taper socket can consist of elastic materialin such a manner that it can be pushed on the plug pin and encloses itelastically after being pushed on.

In a somewhat modified embodiment the interlocking element is a anattached or mounted split taper socket which is formed to produce acoupling in the longitudinal direction of the guide wire in its arealying in a lumen of the electrode line, and thus a force-lockingengagement between the guide wire and the electrode line. This splittaper socket can, on the one hand, be displaceably mounted on the guidewire or, on the other hand however, be an attached or mounted splittaper socket. It is formed to produce a coupling in the longitudinaldirection of the guide wire in its area lying in a lumen of theelectrode line, and thus a force-locking engagement between the guidewire and the electrode line.

For the realization of said coupling it has in particular twolongitudinal holes adjacent to one another in the longitudinal directionbut not concentric to one another where the diameter of the first,proximal longitudinal hole is matched to the outer diameter of the guidewire and the diameter of the second, distal longitudinal hole is matchedto the outer diameter of a plug pin of the electrode line.

The electrode line proposed in addition for the realization of theexisting objective has, in preferred embodiments, fixation means whichcorrespond in principle to the above-mentioned fixation means on theguide wire.

In a first embodiment such an electrode line has an elastic stopper,inserted in a lumen of the electrode line, with a central hole, which isdimensioned in such a manner that it effects force-locking engagementwith the electrode wire at a predefined retaining force. Said stopperis, in a particularly simple manner, inserted at the proximal end of theelectrode line in a plug pin located there. In a somewhat modifiedembodiment it has a longitudinal hole disposed eccentrically and/orinclined to the longitudinal axis, said longitudinal hole, on insertionof the guide wire, effecting a coupling in the longitudinal extension ofthe same in the lumen, and thus a force-locking engagement between theguide wire and the electrode line. This latter embodiment therefore actssimilarly to an embodiment of the aforementioned split taper socket onthe guide wire.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages and expediencies of the invention in other regards followfrom the subordinate claims as well as the following, schematicdescription of preferred embodiment examples with the aid of thefigures. Shown by these are:

FIGS. 1A and 1B schematic perspective representations of a first form ofembodiment of a guide wire according to the invention,

FIGS. 2A and 2B schematic perspective representations of a second formof embodiment of a guide wire according to the invention,

FIGS. 3A and 3B schematic perspective representations of a third form ofembodiment of a guide wire according to the invention,

FIGS. 4A to 4C schematic representations (longitudinal sectionalrepresentations or frontal view of the split taper socket) of a fourthform of embodiment of a guide wire according to the invention, and

FIG. 5 schematic longitudinal sectional representation of a modificationof the fourth form of embodiment.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A and 1B show, in schematic perspective representations (in FIG.1B partially sectioned), the proximal end of an implantable electrodeline 101 with a multipole plug 103, which includes a plug pin 105, withan introduced guide wire 107 with grip piece 109. In FIG. 1B it is to beseen that the electrode line 101—including the plug 103—has a centrallumen 111, through which the guide wire 107 goes.

Near to the proximal end of the guide wire 107, shortly before it joinsthe grip piece 109, the guide wire has a curved deformation 113 whoseeffective diameter increases to a value greater than the inner diameterof the lumen 111. As FIG. 1B shows, on pushing the guide wire into thelumen 111 up to a point beyond the position of the deformation 113 awavy elastic deformation of the corresponding section of the guide wiretakes place. This leads to an elastic contact pressure of the guide wireat several points of the inner wall of the lumen 111, whereby africtional lock between the guide wire 107 and the electrode line 101 isproduced.

With structuring of the deformation 113 which is appropriate and matchedto the elasticity properties of the guide wire and the coefficient offrictional drag between the guide wire and the wall of the lumen, thefrictional force is sufficient to hold the guide wire securely in theelectrode line during all the manipulations occurring in connection withintroduction of the electrode line into the heart of a patient. Afterfinishing the implantation, the guide wire 107 can once again be pulled,at the grip piece 109, out of the electrode line with the electrode line101 fixed in the area of the plug 103 when this frictional force issurmounted.

In FIGS. 2A and 2B an additional arrangement of an electrode line 201with a plug 203 as well as a corresponding plug pin 205 and a guide wire207 with grip piece 209, is represented. Here, for fixation of the guidewire in a lumen 211 of the electrode line 201, a wedge-like cap 213 isprovided on the guide wire 207 in the immediate vicinity of the distalapical face of the grip piece 209. As is to be seen in FIG. 2, onintroduction of the guide wire into the lumen of the electrode line, thewedge 213—which preferably consists of a material with a highcoefficient of friction with respect to the material of the wall of thelumen 211—is partially pushed into the lumen. In so doing it is pressedagainst the outermost proximal section of the lumen wall, and africtional lock also arises here, which (assuming suitable choice ofmaterial and dimensioning) holds the guide wire 207 securely in theelectrode line 201 during any manipulation.

As an additional form of embodiment, an additional arrangement of anelectrode line 301 with plug area 303 and plug pin 305 and a guide wire207 with grip piece 309 is represented in FIGS. 3A and 3B, once againschematically. Here an annular elastomer extension 313 at the distal endof the grip piece 309 is provided as an interlocking element, acting viaa force-lock, between the electrode line and guide wire.

As is illustrated in FIG. 3B, the elastomer extension (for example,rubber ring) 313 surrounds the circumference of the plug pin 305 andexerts on it an elastic contact force. It can be adjusted again bysuitable choice of material and dimensioning of both parts in such amanner that the guide wire is held securely in the electrode line forthe duration of the implantation process and nevertheless is relativelyeasy to remove from it once again after the introduction is finished.Instead of an elastomer a relatively hard thermoplastic part can also beused here.

In FIGS. 4A to 4C an additional embodiment is represented schematically,in which an electrode line 401 with plug area 403 and plug pin 405 isplugged onto a guide wire 407 which has a grip piece 409. Here, as alocking element between the electrode line 401 and the guide wire 407, aseparate split taper socket 413 is provided which can be displaced onthe guide wire, said split taper socket having two longitudinal holes415 a, 415 b adjacent to one another in the longitudinal direction withdifferent diameters and disposed eccentrically to one another.

As FIG. 4C shows schematically in the state of the guide wire 407introduced into a lumen 411 of the electrode line 401, on pushing thedistal longitudinal hole 415 a of the split taper socket 413 onto theplug pin 405, a coupling of the guide wire in its longitudinal extensionis effected. This leads to a pressing of the same against the wall ofthe hole 415 b near its distal and proximal end. Since at the same timethe split taper socket 413 is formed, with regard to its dimensions andchoice of material, in such a way that the plug pin 405 is also fixed inthe hole 415 a by a frictional lock, fixation between the guide wire andelectrode line results overall. This prevents the former from slippingout of the latter as a consequence of manipulations during theimplantation process. In the area of the distal hole 415 a the splittaper socket 413 has a connection window 416, via which, if required,the plug pin 405 can be contacted electrically from outside.

If during the implantation of the electrode line 401 the correctposition for the guide wire found, the split taper socket 413 is pushedonto the plug 403, where the plug pin 405 penetrates into the distalhole 415 a of the split taper socket. In so doing, due to the axialoffset of the holes 415 a, 415 b in the split taper socket, saidcoupling or oblique position of the guide wire 407 is produced, whichleads to locking between the guide wire and electrode line. Theelectrode line can then be pushed further forward without the guide wirebeing able to change its position relative to it. After the implantationis finished, the split taper socket 413 is pulled out of the electrodeplug 403 once again and then the guide wire 407 can also be pulled, atthe grip piece 409, out of the electrode line once again without furthereffort.

In FIG. 5 a modified realization of the latter functional principle withan electrode line 501 (with plug 503 and plug pin 505, consistent withthe embodiment according to FIGS. 4A to 4C) and a guide wire 507 with agrip piece 509 acting at same time as split taper socket is represented.The grip piece 509 has a design substantially consistent with the designof the split taper socket 413 according to FIGS. 4A to 4C, where theguide wire is held in a fixation stopper 510, which is integrated in theproximal end of the grip piece. A connection window (denoted by 516) isalso provided here.

The embodiment of the invention is not restricted to the examplesdescribed above, but rather is just as well possible in a plurality ofmodifications, which lie within the scope of practice according to theart.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to practice the invention, including making and using any devices orsystems and performing any incorporated methods. The patentable scope ofthe invention is defined by the claims, and may include other examplesthat occur to those skilled in the art. Such other examples are intendedto be within the scope of the claims if they have structural elementsthat do not differ from the literal language of the claims, or if theyinclude equivalent structural elements with insubstantial differencesfrom the literal languages of the claims.

1.-17. (canceled)
 18. A method of implanting an electrode line, inparticular a heart electrode line for at least one of intracardialsensing of cardiac action potentials and electrical stimulation anddefibrillation of a heart, into one of a human body and an animal body,comprising: inserting a guide wire into a lumen of the electrode line;engaging a frictional element and a portion of the electrode line in africtional locking manner by relative motion in a longitudinal directionof the guide wire to facilitate coupling the guide wire to the electrodeline; inserting the guide wire together with the electrode line into oneof the human body and the animal body; disengaging the frictionalelement from a portion of the electrode line; and removing the guidewire from the lumen of the electrode line.
 19. A method in accordancewith claim 18, wherein engaging a frictional element and a portion ofthe electrode line further comprises engaging a frictional element and aportion of the electrode line to substantially prevent a longitudinaldisplacement of the frictional element relative to the electrode line.20. A method in accordance with claim 18, wherein engaging a frictionalelement and a portion of the electrode line further comprises deformingthe guide wire via the relative motion in the longitudinal direction ofthe guide wire.
 21. A method in accordance with claim 18 furthercomprising providing the frictional element with a socket defining abore configured to receive a portion of the guide wire.
 22. A method inaccordance with claim 18 further comprising providing the frictionalelement with one of a wedge-shaped element and a conical element suchthat the frictional element is formed on or fixedly provided on theguide wire.
 23. A method in accordance with claim 18, wherein engaging africtional element and a portion of the electrode line further comprisesenlarging an effective contact diameter of the guide wire to a diameterat least equal to an inner diameter of the lumen.
 24. A method inaccordance with claim 23, wherein enlarging an effective contactdiameter of the guide wire further comprises deforming a portion of theguide wire into one of a curved, a wavy, a V-shaped, a zig-zag and atrapezoidal shape.
 25. A method in accordance with claim 18, whereininserting the guide wire together with said electrode line into the oneof the human body and the animal body further comprises inserting theguide wire together with the electrode line into a vascular system ofone of the human body and the animal body.
 26. A method in accordancewith claim 18, wherein engaging a frictional element and a portion ofthe electrode line in a frictional locking manner further comprisesengaging the guide wire securely in the electrode line during anintroduction of the guide wire together with the electrode line into thevascular system.
 27. A system for introducing an implantable electrodeline into a body, said system comprising: a guide wire comprising adeformed portion configured to enlarge an effective contact diameter ofsaid guide wire; an electrode line comprising: a lumen configured toreceive a first portion of said guide wire and engage the deformedportion such that said guide wire is substantially parallel to an innersurface of said lumen; and a stopper inserted within said lumen, saidstopper comprising a longitudinal hole oriented eccentrically to alongitudinal axis of said electrode line, the longitudinal hole, uponinsertion of said guide wire therein, facilitates coupling said guidewire within said lumen and facilitates a force-locking engagementbetween said guide wire and said electrode line.
 28. A system inaccordance with claim 27, wherein the deformed portion comprises one ofa wedge-shaped element and a conical element formed on or fixedlyprovided on said guide wire, the deformed portion configured to enlargean effective contact diameter of said guide wire to a diameter at leastequal to an inner diameter of said lumen.
 29. A system in accordancewith claim 28, wherein the deformed portion has one of a curved, a wavy,a V-shaped, a zig-zag and a trapezoidal shape.
 30. A system inaccordance with claim 27, wherein the stopper is inserted at itsproximal end into a plug pin.
 31. A guide wire for introducing animplantable electrode line, in particular a heart electrode line forintracardial sensing of cardiac action potentials and/or for electricalstimulation or defibrillation of the heart, said guide wire isconfigured for interlocking with the electrode line, said guide wirecomprises a deformation configured to enlarge an effective contactdiameter of said guide wire to a value corresponding essentially to aninner diameter of a lumen of the electrode line.
 32. A guide wire inaccordance with claim 31 wherein said deformation comprises one of awedge-shaped element or a conical element fixedly provided on said guidewire, said deformation comprising an engagement section tapering towarda distal end of said guide wire.
 33. A guide wire in accordance withclaim 31, wherein said deformation comprises one of a curved, a wavy, aV-shaped, a zig-zag, or a trapezoidal shape.
 34. A guide wire inaccordance with claim 31 further comprising a split taper socketconfigured to engage a plug pin of the electrode line and to produce aforce-locking engagement with the electrode line.
 35. A guide wire inaccordance with claim 34, wherein the split taper socket is fabricatedfrom an elastic material, the split taper socket is configured toelastically receive and enclose the plug pin.